Market status and outlook for MEMS in drug delivery

Introduction

In the bio-medical field, drug delivery is one of the areas that attract the most attention for MEMS because of its promise to make drug delivery less invasive, more precise and intelligent, less painful, etc. The fact that STMicroelectronics is partnering with a SME in this area – with the full might of its 8” fab – bears witness to the hope for significant volume shipments in this field.

Commercialization cycles are very long, however, not only because of the clinical tests and certification, but also for less obvious business reasons pertaining to the pharmaceutical industry. In this article iSuppli summarizes the status of commercialisation and the market outlook for the next 4 years.

iSuppli has identified 5 typical families of MEMS devices on the market or in R&D for drug discovery as summarized in Table 1.

Commercial status of MEMS for drug discovery today

Table 1: Overview of MEMS for drug delivery

Nebulizersand inhalers are the most mature MEMS technology today. microParts – part of the Pharmaceutical company Boehringer Ingelheim – is now shipping its Respimat Soft Mist inhaler in about 8 countries in Europe corresponding to over 6 to 7 million units in 2009 for asthma and Chronic Obstructive Pulmonary Disease (COPD). FDA approval is expected within 2 years, as the US market is opening, shipments should increase significantly. Medspray and Iridigm are still in R&D. First products should be available in the pharmacy from 2012.

Caption: Respimat Soft Mist inhaler (Courtesy microParts)

Silicon micro-needles are in the clinical test phase in cooperation with pharmaceutical companies.

Regarding hollow micro-needles, the Micronjet device from NanoPass has been tested for influenza vaccine as well as for rabies vaccine. The Micro-Trans device (Valeritas) and Nanoject (Debiotech) are also believed to be in preclinical development according to the World Health Organisation (WHO).

Regarding solid coated microneedles in patch format, metallic and polymer microneedles from respectively Zosano Pharma and 3M are being tested but little is known about the clinical studies with silicon micro-needle in that form.

iSuppli expects first silicon-microneedle medication to ship from 2012.

Noteworthy, the Micronjet from NanoPass has been awarded European Conformity (CE) approval in 2008. The company can now sell its microneedle technology for non-medical applications and iSuppli expects first commercial applications for cosmetics use as early as 2010 or 2011.

Portable micro-pumps: First prototypes of the disposable Nanopump insulin pump were announced in June 2008. These ended clinical testing early in 2009. The technology is available; however it is not clear whether the company is cooperating with any major drug delivery system like Medtronics, Johnson & Johnson or Roche to bring the pump to the market. Debiotech announced a cooperation with Animas on the insulin pump in 2004 (since 2006 this is no longer operative, since Animas was acquired by Johnson & Johnson).

Implantable micro-reservoir arrays: MicroCHIPS is in the preclinical testing phase for osteoporosis and is approaching the trials phase. iSuppli anticipates the first medical device to be 3 to 5 years out. Noteworthy, Medtronic is interested in implantable technologies and invested in the start-up.

Caption: Micromachined reservoirs on a chip (MicroCHIPS)

Automatic injection pens: French start-up Eveon is working on a new concept for an automatic injection device using a MEMS pump. The device targets delivery of expensive “living” bio-drugs, therefore the increased accuracy of the dosage is a key advantage. It provides subcutaneous injections like all pens but also allows for intramuscular and intravenous injection. The company’s schedule is to get the certification of the device including MEMS in 2013. The injection device could start selling with medications in 2013 or 2014.

Caption: Injection device (Evion)

The next MEMS killer app?

Caption Potential opportunity for MEMS-enabled drug delivery devices

On paper the total available market (TAM) for MEMS is tremendous as it appears on Figure 1.

In terms of volume, micro-needles have the largest potential, since they are suitable replacement for the billion vaccinations performed every year.

200 million people suffer from osteoporosis worldwide and could benefit from an implantable therapy such as developed by MicroCHIPS.

The World Health Organization (WHO) estimates that more than 180 million people worldwide have diabetes. This number is likely to more than double by 2030. About 40 million of them (e.g. 5 million in the USA) require daily insulin injections and need to closely monitor their glucose levels. These diabetics are the target for Debiotech’s micropumps.

Bio-drug treatments are developed for volumes starting typically at around 500,000 injections yearly. It means that the potential for Eveon’s MEMS based injection device is several million units yearly.

One should not take these numbers as market potential numbers for MEMS in 5 years however, and not even 10 or even 20 years, considering the long certification cycles for the market. Market boundaries are complex in the pharmaceutical industry.

The price must be right!

This statement is not specific to drug delivery systems, but determining the acceptable price of the MEMS based hardware is tricky in drug delivery.

Let’s consider the example of silicon micro-needles, which face the highest price pressure. Conventional disposable needles cost around $0.15 today. Developers of silicon micro-needles hope to sell these for $0.50. They justify this higher price by some intrinsic cost advantages brought by micro-needle technology as summarized by WHO (reduction of needle stick injuries and associated costs, dose sparing, patch based micro-needle might need less cold chain volume…) as well as the better delivery and high patient acceptation (pain-free).

However it is difficult to tell today if health insurance organizations (the policies of which also differ by country) will tolerate this cost difference. Also, manufacturers of silicon micro-needles must also consider the competition from polymer micro-needles, which may be manufactured at a lower price.

One should not only consider the cost of the hardware. An expensive drug can allow for a premium on the delivery hardware, e.g. with inhalers, the drug for COPD is more costly than for asthma (€60 and €30 respectively in pharmacy) and can more easily support the estimated €10 for hardware (about 1.50 € for the MEMS nozzle plate).In the case of diabetes, it is difficult to assess if a MEMS based disposable pump will be competitive. As an alternative to simple injections, conventional pumps have proven to deliver more precise amounts of insulin and to improve treatment, but have a significant cost of ownership with a starting price of $6,000-$7,000 for a four year life, which the insurance company pays upfront as about 50% of the total cost of covering the treatment. The rest of the treatment cost is for fixed cost disposables like the syringe and infusion set. The cost of a disposable MEMS patch pump as developed at Debiotech would then have to be included in the total treatment cost, which for diabetes is $12 a day. At today’s pricing with a 3-day charge of insulin, the MEMS micro-pump is still too expensive. One way would be to increase the insulin charge by at least two times to halve the consumable cost, which would be a significant step forward for micro-pumps. This approach is technically feasible but will be subject to regulatory issues as the FDA decides if the insulin can be stored for 6 days at room temperature.

Caption: Chip made by ST supporting a durable insulin pump from Debiotech

Being acquired by a pharmaceutical company: the ultimate goal?

Since the drug delivery systems are intrinsically linked to the drug, being acquired by a pharmaceutical company looks like a natural exit for MEMS drug delivery companies. microParts was acquired by Boehringer Ingelheim in late 2004 and has successfully commercialized the first MEMS drug delivery system since.

This model limits the commercialisation of the drug delivery systems to the new molecules of the mother company, though. iSuppli did notice however that most other MEMS start-ups in this field try to remain independent, avoiding exclusivity and hoping for multiple partnerships and licensing agreements with pharmaceutical companies and thereby a higher return on investment.

Long and slow is the path…

Everyone is aware of the length of the preclinical and clinical test phases and the time required to obtain the certification in each country, and ultimately getting the FDA approval that opens the door to the US market. There are others factors that slow down the adoption of a system once its certified. Ramping up production not only for the MEMS part but also for the full system can be challenging, as every machine has to be certified. This took microParts several years, for example.

Finally, once a drug delivery system is certified, one should not expect a rapid deployment on all relevant existing molecules. A pharmaceutical company has actually no financial interest in adopting a new drug delivery system for an existing established drug unless it can improve market growth through usability or protect a molecule from going off patent. It means that deployment will be not massive but stepwise.

2013 market outlook

iSuppli’s market window is typically 4 years ahead. By 2013, iSuppli expects inhalers still to account for most of the market for MEMS in drug delivery. New players like Medspray and Iridigm should join Boehringer microParts by then.

First silicon microneedles should also ship by this time, first for cosmetics applications and then for vaccinations.

In the field of implanted micro-reservoir arrays, MicroCHIPS has attracted leading device and pharmaceutical investors. It must now demonstrate that it can move from the preclinical to the clinical phase with a device that is commercially attractive.

It is still unclear if by 2013 disposable insulin micro-pumps and implantable micro-reservoir arrays will be implanted. The price must be right, the partnership between ST and Debiotech should help, but also one of the established companies in this field would need to embrace the technology and there is little evidence for it happening right now.

THIS ARTICLE IS AN EXCERPT FROM iSUPPLI’S NEWSLETTER: “MONTHLY MEMS MARKET BRIEF”. PLEASE CONTACT iSUPPLI IF YOU WISH TO SUBSCRIBE.

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Dear Sir/Madame,
I would be very interested to receive your monthly updated newsletter relating to MEMS, Biomedical, Drug Delivery systems and in particular information about the use of Silicon Microneedles as delivery mechanism.